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A Phase I Study of De-Immunized DI-Leu16-IL2 Immunocytokine in Patients With B-Cell Non-Hodgkin Lymphoma
RATIONALE: Biological therapies, such as fusion protein cytokine therapy, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fusion protein cytokine therapy together with rituximab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of fusion protein cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin lymphoma.
Details
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 9 |
| Start date | 2008-01 |
| Completion | 2014-07 |
Conditions
- Anaplastic Large Cell Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Intraocular Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Marginal Zone Lymphoma
Interventions
- DI-Leu16-IL2 immunocytokine
- rituximab
- flow cytometry
- immunohistochemistry staining method
- pharmacological study
- laboratory biomarker analysis
- enzyme-linked immunosorbent assay
- reverse transcriptase-polymerase chain reaction
Primary outcomes
- Maximum tolerated dose of DI-Leu16-IL2 — 6 weeks post cycle 1 of treatment
- Optimal biologic dose of DI-Leu16-IL2 — 6 weeks after final cycle of treatment
- Toxicities associated with the DI-Leu16-IL2 regimen — 6 weeks after final cycle of treatment
Countries
United States